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Cardiogenesis Transmyocardial Revascularization Registry

NCT01827319 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 203

Last updated 2016-08-15

Study results available
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Summary

The objectives of the registry are as follows:

* Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System;
* Further define the disease characteristics of the population being treated;
* Examine transmyocardial revascularization (TMR) usage characteristics and 30-day outcomes;
* Further assess the 30-day postoperative risk factors for adverse events. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria are to be offered the opportunity to enroll in the study at participating centers.

Conditions

  • Class IV Angina

Sponsors & Collaborators

  • Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Capps, MS · CryoLife, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827319 on ClinicalTrials.gov